Radiology AI Directory

FDA-cleared profile

Rapid Aortic Measurements

iSchemaView, Inc.

Aortic and iliac artery segmentation, visualization, measurement, and longitudinal tracking as adjunctive physician decision support.

Quantification and segmentation
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Aortic and iliac artery segmentation, visualization, measurement, and longitudinal tracking as adjunctive physician decision support.
FDA source Exact FDA submission Checked 2026-09-08
Intended users
Radiologists, cardiothoracic surgeons, vascular surgeons, endovascular specialists, ED physicians, or users with similar training
FDA source Exact FDA submission Checked 2026-09-08
Care setting and population
Adult
Public source Exact FDA submission Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Segmentation, vessel visualization, measurement, and longitudinal-tracking support integrated with physician review; adjunctive to clinical decision-making.
FDA source Exact FDA submission Checked 2026-09-08
Required input
DICOM axial CT datasets of the chest, abdomen, and/or pelvis, including NCCT, CECT, CTA, and CTPA, for adults; the packet specifies target-zone, field-of-view, pixel-spacing, slice-spacing, slice-thickness, tube-voltage, and image-order requirements.
FDA source Exact FDA submission Checked 2026-09-08
Output and human action
Aortic and iliac centerline measurements; maximum oblique diameter by aortic zone; fixed aortic and left/right iliac measurements; 3D volume renderings; rotations; iliac CPRs; aortic oblique MPRs; longitudinal tracking; and segmented-vessel visualizations.
FDA source Exact FDA submission Checked 2026-09-08
Limitations
Results are not standalone clinical decisions. Excessive motion or metal implants may reduce output quality. The packet excludes cone-beam CT, non-axial or excessively oblique series, improperly ordered or materially missing slices, inadequate target-zone coverage, and datasets outside the stated FOV, pixel-spacing, slice-spacing, slice-thickness, or 70-150 kVp limits.
FDA source Exact FDA submission Checked 2026-09-08

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K251987
FDA source Exact FDA submission Checked 2026-08-31
Modality
CT/CTA
FDA source Exact FDA submission Checked 2026-09-08
Anatomy
Aorta, iliac arteries, and major branching vessels in the chest, abdomen, and/or pelvis
FDA source Exact FDA submission Checked 2026-09-08
Clearance type
510(k)
FDA source Exact FDA submission Checked 2026-08-31
Decision date
2025-09-23
FDA source Exact FDA submission Checked 2026-08-31
FDA status
FDA-cleared
FDA source Exact FDA submission Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Rapid Platform provides DICOM filtering, job and interface management, accepts DICOM images, and returns processed DICOM images to the source imaging modality or PACS. The packet describes on-premises installation behind the customer firewall or a hybrid on-premises/cloud configuration; specific local interface compatibility is not established.
FDA source Exact FDA submission Checked 2026-09-08
Deployment and data flow
Hybrid
Public source Exact FDA submission Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Rapid Aortic Measurements; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary
FDA performance validation used 108 NCCT, CTA, or CECT/CTPA cases from 115 patients, with up to three clinical experts comparing outputs with source DICOM images. Primary endpoints included 100% agreement for VR segmentation/clinical accuracy, CPR/MPR quality, anatomical labeling, and maximum-oblique-diameter zone location. Quantitative results included average VR Dice 0.93, VR Hausdorff distance 0.54 mm, CPR/MPR Hausdorff distance 0.59 mm, ground-truth reproducibility Dice 0.95, and measurement-report mean absolute error 0.22 cm.
FDA source Exact FDA submission Checked 2026-09-08
Reported sensitivity
Research pending
Needs research Exact FDA submission Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
Needs research Exact FDA submission Checked 2026-08-31

This field has not been curated yet.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Rapid Aortic Measurements regulatory performance study summary

Stand-Alone Performance · Adult

exact submission · Tested version: Exact product version not reported; regulatory study summarized for FDA submission K251987 · n=108 · Independence not established

K251987

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

Economics and lifecycle

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-08

No public price or quote for the exact K251987 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The exact-identifier FDA recall query returned no native recall record for K251987. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Public source Exact FDA submission Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-08Last searched
22Fields reviewed
9Source classes checked
0Unreviewed PubMed leads
0Unreviewed trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-08.

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